‘Tis the season for giving, but it’s not quite keeping in the spirit to have our Environmental Protection Agency (EPA) pile on giveaways to the chemical industry. The latest one I’ll discuss in this post is not only in direct violation of the Toxic Substances Control Act (TSCA); it exposes this EPA’s two-facedness when it comes to making public the information EPA relies on in making regulatory decisions that affect our health and our environment.

EPA’s failure to make health and safety studies available to the public is blatantly illegal and a slap in the face to the 2016 bipartisan reforms to TSCA that sought to increase public access to information on chemical risks.

First some background. It has been a long time since EPA has proposed a rule to require testing to determine the hazards of a chemical; the last time was way back in 2011. (That proposed rule was never finalized. And despite Congress’ major expansion of EPA’s authority to require testing when reforming TSCA in 2016, EPA has steadfastly refused to even consider use of that new authority.)

The American Chemistry Council (ACC) filed comments opposing the 2011 proposed rule. As I blogged about at the time, ACC insisted that, instead of calling on its members to provide the health and safety data sought through the proposed rule, EPA should seek to get it from the European Chemicals Agency (ECHA). ACC asserted that ECHA likely had already received the requested data under the European Union’s (EU) REACH Regulation. I noted that’s not as easy as it sounds, because the chemical industry itself has thrown up major roadblocks to such inter-governmental data sharing. But here’s the rub: ACC further argued that, should EPA succeed in obtaining the health and safety data submitted to ECHA, EPA could and should deny public access to those data – despite the fact that TSCA clearly prohibits EPA from withholding health and safety studies. ACC added that the public should make do with mere summaries of the studies, summaries that were prepared by the companies making the subject chemicals.

At the time, EPA was having none of this. It indicated that if necessary it could use, and was considering using, its subpoena authority under section 11(c) of TSCA to get the studies from the companies that had submitted them to ECHA; see pages 16-17 of this 2013 report from the Government Accountability Office (GAO).

This is our final post in a series spurred by our review of 69 public files for new chemicals we received from EPA’s Docket Center. For most of these chemicals, EPA made a determination that they are “not likely to present unreasonable risk” under the Toxic Substances Control Act (TSCA), which greenlights their entry into commercial production.

In our previous post we demonstrated EPA is not complying with a number of provisions under TSCA that require the agency to make public the premanufacture notices (PMNs), notices of commencement (NOCs), and information that is submitted with them. In this post we look further into how, through these failures and others, EPA has impeded meaningful transparency in the new chemicals program.

As originally enacted in 1976, TSCA recognized the value of public access to information, like health and safety information (see, e.g., TSCA § 14(b)). Even in EPA’s original (1983) regulations establishing the new chemicals review program, EPA recognized that “[p]ublic participation cannot be effective unless meaningful information is made available to the interested persons” (see here p. 21737). Among the many flaws of the original TSCA, however, was the law’s inability to ensure EPA delivered the promised transparency when it came to both information EPA receives and the agency’s decisions on new chemicals.

The amendments to TSCA in 2016 were meant, in part, to expand public access to information about both chemicals and agency decisions, and in doing so increase public confidence. For instance, under § 26, EPA must now make available to the public “all notices, determinations, findings, rules, consent agreements, and orders.” And under § 5, EPA must now make an affirmative determination on new chemicals, which under § 26 must be made public. These changes, in addition to the original TSCA provisions, clearly envision a robust program under which the public is able to readily access non-confidential information on new chemicals and information on EPA’s decisions about them.

Coupled with the policy changes EPA has made, the concerns we raise here make clear that EPA under this Administration intends to weaken a new chemicals program that Congress sought to strengthen through TSCA reform – and hide as much of it from public view as possible.

As implemented, however, a number of features of the new chemicals program severely hamper the ability of the public to understand EPA’s decision-making or engage in the new chemicals program. In addition to the failings we have discussed in previous posts in this series, this post will address several others:

the convoluted and fragmented public information “system” EPA has created for PMNs;

the failure of EPA to provide access to agency-generated health and safety information on PMN substances; and

EPA’s failure to publish Notices of Commencement (NOCs) and EPA’s determinations on confidentiality claims for specific chemical identity in those NOCs.

One of the key reforms to the Toxic Substances Control Act (TSCA) made by 2016’s Lautenberg Act was the expansion of who can access confidential business information (CBI) submitted by companies to EPA. The old law largely limited access to federal government employees and contractors. Congress recognized the enormous value such information could provide to officials at other levels of government and to health providers and environmental officials treating or responding to chemical releases and exposures. It therefore mandated that EPA expand CBI access, subject to certain conditions specified in the law.

This is the third in a series of blog posts based on our frustrating, and frustrated, efforts to get information on premanufacture notifications (PMNs) for new chemicals under the Toxic Substances Control Act (TSCA). The saga began when we requested from the EPA Docket Center the public files on 69 new chemicals, most of which EPA had determined were “not likely to present an unreasonable risk” under the TSCA, as amended in 2016 by the Lautenberg Act. This series of posts analyzes and describes what we did, and did not, get from the Docket Center, to which EPA staff pointed us when we raised the fact that such files are not available on EPA’s website or at www.regulations.gov, despite EPA regulations requiring they be.

TSCA and EPA’s regulations contain a number of provisions that, if reliably implemented, would give the public better access to, or at least a better understanding of, the information EPA receives on new chemicals. This includes mandates that EPA:

make all PMNs and Significant New Use Notices (SNUNs) publicly available (TSCA § 5(d)(1));

make all information submitted with the notices available to the public (TSCA § 5(b)(3) and 40 C.F.R. § 720.95); and

make the public files electronically available (40 C.F.R. §§ 700.17(b)(1), 720.95).

EPA has repeatedly committed to increasing the transparency of its new chemicals program. Unfortunately, our review of the PMN files we received has revealed massive gaps and inconsistencies in the information EPA does provide to the public, and all too often we are finding that EPA has entirely failed to comply with the law and its own regulations. These failings are on top of efforts by the agency to actively hide information on new chemicals that it had made public for decades.

This post will focus on failings of EPA’s new chemicals program when it comes to transparency and compliance with TSCA and its own regulations with respect to the PMNs EPA receives for new chemicals. These failings make it virtually impossible for the public to gain any understanding of, or play any meaningful role in, EPA’s review of new chemicals under TSCA. Read More »

Our Brief argues in favor of the public’s right to know. Among other arguments, it explains that EPA erred by allowing companies to assert “Confidential Business Information” (CBI) claims that do not meet the law’s requirements. As a result, EPA will be concealing information about chemicals, particularly information about specific chemical identities, in violation of the public’s right to know. EDF also filed our two-volume Addendum supporting EDF’s standing to pursue this lawsuit. The Addendum proves that EDF uses this kind of information to study and communicate to the public about chemicals and to advocate for measures to protect public health.

We recently started a series of blog posts describing what we did, and did not, get from the EPA Docket Center when we requested the public files on about 70 new chemicals, most of which EPA had determined were “not likely to present an unreasonable risk” under the Toxic Substances Control Act (TSCA), as amended in 2016 by the Lautenberg Act. To continue our series, we address in this post EPA’s pervasive failure to require companies to adequately substantiate Confidential Business Information (CBI) claims, and its own apparent failure to review such claims, despite clear requirements to do so under § 14 of TSCA.

Twenty months after passage of the Lautenberg Act, we simply must ask: When will EPA start carrying out its new responsibilities on CBI claims – which includes compelling companies to comply with the law?

First, to provide some context, let us address a question we were asked based on our first post: whether the PMN situation we are describing is any worse now than it was pre-Lautenberg Act. We suspect it is not necessarily worse. However, the purpose of the reforms to CBI in the Lautenberg Act was to fix these problems, by requiring substantiation and EPA review of most CBI claims, including those asserted in premanufacture notifications (PMNs) submitted for new chemicals. By and large it appears this is simply not happening, 20 months after the law passed and those provisions took effect.

Few of the PMN public files we received included any substantiations, despite massive assertions of CBI claims that require substantiation; instead, companies simply redacted the information. In addition, nearly all of those submissions that do include a substantiation document are wholly inadequate, routinely claiming information as CBI that is not eligible for nondisclosure or failing to provide justification for information that may be eligible. The violations are so egregious that they indicate EPA is failing to conduct even a cursory review of the claims and redactions. Read More »